Amgen Specialist Quality Assurance in Woburn, Massachusetts
2nd Shift: 3:00pm - 11:00pm (Monday - Friday)
Responsible for all quality oversight functions related large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured Amgen.
Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations
Ensures that facilities, equipment, materials, processes, procedures and products comply with cGMP practices and other applicable regulations
Responsible for ensuring raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas meet GMP requirements
Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non-conformances, CAPAs, change control records and validations.
Ensures that changes that could potentially impact product quality are assessed according to procedures
Ensures that deviations from established procedures are immediately triaged, investigated and documented per procedures
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks
Alerts senior management of significant quality, compliance, supply and safety risks
Perform AQL for Visual Inspection
Release of gases, cell banks and labels
Oversight the Aseptic Processing filling and provide advice and guidance during the process
Master's degree and 3 years of Quality experience
Bachelor's degree and 5 years of Quality experience
Associate's degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
Previous experience in Quality Systems (e.g. Investigations, CAPAs, Change Controls)
Validation experience (e.g. cleaning, sterilization and computer related systems) and/or compliance areas
Ability to manage multiple priorities at the same time.
Demonstrated proficiency using Excel, Word and Power Point
Strong interpersonal skills
Excellent written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.